IR 05000483/1993021
| ML20029C552 | |
| Person / Time | |
|---|---|
| Site: | Callaway  |
| Issue date: | 02/15/1994 |
| From: | Creed J, Pirtle G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20029C551 | List: |
| References | |
| 50-483-93-21, NUDOCS 9403090029 | |
| Download: ML20029C552 (9) | |
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U.S. NUCLEAR REGULATORY COMMISSION REGION Ill Report No. 50-483/93021(DRSS)
Docket No. 50-483 License No. NPF-30 Licensee:
Union Electric Company St. Louis, MO 63166 Facility Name:
Callaway County Nuclear Power Station, Unit 1 Inspection Dates: November 29-December 3, 1993 onsite December 21, 1993 to February 11, 1994 in NRC Region !!!
Office Type of Inspection: Announced Fitness-For-Duty inspection Date of Previous Fitness-For-Duty Inspection: July 24-27, 1990 Inspector:
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I-bGaryL.Pirtle Date
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Physical Security Inspector
Approved By:
h he James R. Creed, Chief Date j Safeguards and IR Section e
Insoection Summary Jnspection Between November 29. 1993 and February 11. 1994 (Deport No. 50-483/
93021(DRSS))
Areas Insoccted:
Routine, announced inspection of the licensee's fitness-For-Duty (FFD) Program required by 10 CFR Part 26.
The inspection included:
Management Support; FFD Facilities and Procedures; Specimen Collection Process; FFD Personnel Background Checks and Psychological Eva'luations; Audits and Surveillances of the FFD Program; FFD Trends and Analysis; Monthly Lab Reports Provided to the Licensee; Blind Sample Test Program; FFD Semiannual Performance Data and Followup on Previous Inspection Findings.
Results1 The licensee was found to be in compliance with NRC requirements within most areas examined. However, an unresolved item was identified pertaining to a failure to conduct annual audit requirements for the two contract laboratories used to fulfill FFD program requirements.
This unresolved item will be referred to the Office of General Counsel for review.
Inspection results also included findings pertaining to:
the need to revise a procedure to address the appeal process for contractors (See Section 5.b); the need for more effective written instructions for personnel being FFD tested (See Section 5.c); and the need for more adequate control of possible access to quantitative FFD test result data (See Section 5.d).
Three strengths were 9403090029 940223 PDR ADOCK 05000483 G
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noted involving:
the size and quality of the FFD facilities; the competence
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and knowledge of the FFD staff; and the self audits = of the onsite elements of the FFD program (See Section 5.e).
Two -incidents of premature access authorization were reviewed and determined to be licensee identified violations (See Section 6).
Two security-relnisi previous inspection findings were reviewed and closed (See Section 2).
Licensee management support for the FFD program centinued to be strong and the program was receiving effective oversight and supervision on a day-to-day basis.
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DETAILS 1.
Persons Contacted
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In addition to the key members of the licensee's staff listed below, the inspector interviewed other employees, contractor personnel, and members of the security and fitness-for-duty staff. The asterisk (*) denotes those present at the onsite Exit Interview conducted on December 3, 1993.
Licensee Staff
- G. Randolph, Vice President, Nuclear Operations, Union Electric (UE)
J. Pevey, Manager, Operations Support, UE J. Laux, Manager, Quality Assurance, UE
- G. Pendergraff, Superintendent, Security, UE
- R. Rist, Assistant Superintendent, Personnel, UE
- R. Hertz, Supervisor, Access Control, UE
- G. Hamilton, Supervising Engineer, Quality Assurance, UE
- K. Barbour, Engineer, Quality Assurance, UE
- S. Petael, Engineer, Quality Engineer, UE
- E. Thornton, Quality Assurance Auditor, UE
- P. Davis, Registered Nurse, Fitness For Duty, UE
- K. French, Registered Nurse, Fitness For Duty, UE Nuclear Reaulatory Commission
- B. Bartlett, Senior Resident Inspector, NRC Region III
- D. Calhoun, Resident Inspector, NRC Region III
- S. Lee, NRC Intern, NRC Region III 2.
Followuo on Previous insoection Findinas a.
(Closed) Insoection Followuo item (Report No. 50-483/93013-02).
This item was addressed in Section.4.b of the above report and pertained to the need to revise the security plan to correctly describe the secondary power supply systems for the exterior remote multiplexer unit buildings.
The necessary security plan change was submitted on November 1, 1993. The adequacy of the security plan change will be addressed by separate correspondence.
This item is considered closed.
b.
(Closed) Inspection Followuo item (Report No. 50-483/93013-03).
This item was discussed in Section 4.c of the above report and pertained to the need to revise the Security Force Training and Qualification (SFT&Q) Plan and some task evaluation certification forms to correctly identify how job task evaluations are performed. A review of selected task evaluation forms showed that the necessary changes had been made. The change to the SFT&Q Plan was submitted on November 1, 1993. The adequacy of the change
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will be addressed by separate correspondence.
This item is considered closed.
3.
Entrance and Exit Interviews a.
At the beginning of the inspection, Mr. R. Rist of the licensee's staff was informed of the purpose of this inspection, it's scope and the topical areas to be examined.
b.
The inspector met with the licensee representatives, denoted in Section 1, at the conclusion of onsite inspection activities. A general description of the scope and conduct of the inspection was provided.
Briefly listed below are the findings discussed during the exit interview. The licensee representatives were invited to provide comments on each item discussed.
Those comments are included. The details of each finding listed below are referenced, as noted, in the report.
(1)
Personnel present were advised that a potential violation had been noted pertaining to failure to conduct annual audits of the two contract laboratories used to fulfill Fitness-For-Duty (FFD) program requirements (See Section 5.a).
The licensee's staff stated that, in their judgement, their review of the rule and related FFD program documents identified no requirement to conduct annual audits of the Health and Human Services (HHS) certified laboratories used for their FFD program.
The staff acknowledged that a pre-award audit of HHS laboratories before being used was required and they had completed such audits in 1989 and 1990. The Vice President of Nuclear Operations noted that the licensee may submit a letter to the NRC Region III staff explaining their perspective in more detail and the basis for their perspective to assist in resolving the issue.
The licensee's letter, dated December 14, 1993, was received by NRC Region III on December 17, 1993. A copy of the letter is attached as enclosure 3 to this inspection report.
Since this issue involves a question of legal interpretation and is of generic applicability we have decided to forward the issue to the Office of General Counsel.
(2)
Personnel were advised that two open security-related
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inspection items were reviewed and that they would be recommended for closure (See Section 2).
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(3)
Inspection followup items were noted pertaining to:
procedural guidance for the contractor appeal program (See.
Section 5.b), the need for more effective written-instructions for personnel being FFD tested (See Section
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5.c); and more effective access controls for access to laboratory FFD quantitative data (See Section 5.d).
(4)
Three program strengths were noted pertaining to the FFD facilities, the performance and qualification of the FFD staff, and the quality of the audit of onsite FFD functions (See Section 5.e).
(5)
Two incidents of premature access authorization were reviewed and determined to be a licensee identified violation (See Section 6).
4.
Proaram Areas Inspected Listed below are the areas examined by the inspector in which no findings (violations, deviations, unresolved items or inspection followup items) were identified. Only fir, dings are described in subsequent Report Detail sections.
The below listed clear areas were reviewed and evaluated by the inspector.
Sampling reviews included interviews, observations, ana document reviews that provided independent verification of compliance
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with requirements.
Gathered data was also used to evaluate the adequacy of the reviewed program and practices to adequately protect the health and safety of the public. The scope and depth of inspection activities
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were conducted as deemed appropriate and necessary for the Fitness-For-Duty program.
The areas inspected in which no findings were noted and compliance was adequate included: Management Support; FFD Facilities and Procedures; Observed Specimen Collection and Processing; FFD-Personnel Background Checks and Psychological Evaluation; FFD Trends and Analysis; Monthly Lab Summary Reports; and the Blind Sample Test Program.
5.
Fitness-For-Duty Proaram (IP 81502)
One unresolved item, three inspection findings, and three program strengths were noted and are addressed below:
The unresolved item pertained to failure to conduct required a.
annual audits of HHS-certified laboratories used to support the licensee's FFD program (483/93021-01).
An unresolved item is one for which additional information is needed before a decision can be made regarding compliance or non-compliance.
10 CFR 26.80(a) states "Each licensee subject to this part shall audit the fitness-for-duty program nominally every 12 months".
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Additionally,10 CFR 26.80(c) states in part "NRC Guidelines require licensee audits of HHS-certified laboratories as described in Appendix A".
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The licensee uses two Health and Human Services (HHS) certified laboratories (Pharmchem in Menlo Park, CA. and Smith Kline in Chicago, IL.) to perform urine and blood analysis for confirmatory
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FFD testing.
Initial FFD screening tests are conducted onsite by the licensee's testing facility. 'The two HHS-certified laboratories were audited between December 1989 and April 1990 as part of the pre-award inspection prior to award of a contract to the two laboratories. No audits of the HHS-certified laboratories have been conducted by the licensee since the pre-award audits.
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The licensee's staff concluded that the NRC rules do not require an audit of HHS-certified laboratories other than a pre-award audit prior to completion of a contract. The licensee provided a letter to NRC Region III, dated December 14, 1993, which addressed their reasons for their conclusion (See Enclosure 3).
The licensee notes in their letter that the two HHS-certified laboratories are not " contractors" or " vendors" as defined in 10 CFR Part 26.
The licensee further notes in their letter that Section 2.7(m) of Appendix A to 10 CFR Part 26 only requires a pre-award inspection or audit prior to award of a contract. We agree that a pre-award audit of HHS certified laboratories is required and the_ licensee complied with this requirement. However, the question at hand is whether the licensee is required to audit its HHS certified laboratories at nominal 12 month intervals.
Since this question involves an issue of legal interpretation and has generic-applicability we have decided to refer it to NRC's*0ffice of General Counsel.
b.
An inspection finding was noted pertaining to the need to revise a procedure to address the appeal process.for contractors.
10 CFR 26.28 requires licensees to establish a procedure for licensee and contractor or vendor employees to appeal a positive alcohol or drug determination. The licensee had two different procedures with different methods of appeal for contractor and vendor personnel identified in the procedures.
Section 19 of Procedure APA-ZZ-00909 identifies retesting of the urine split sample and/or re-test of the original test specimen by the HHS-certified laboratory performing the initial tests on the specimen
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and discussion with the MR0 as the appeal process for contractor and consultant personnel.
Section 20 of Procedure XDP-PD-0001 identifies the above actions as methods of appeal but also allows the person's individual case to be reviewed by an -internal management review board, as is allowed for licensee employees.
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- There has been no formal appeal requested by a contractor employee so this issue is primarily an administrative issue.
The FFD Program Manager (FFDPM) agreed to revise Section 19 of Procedure APA-ZZ-00909 to allow the appeal process for contractor personnel to include a request for an internal management review board, as currently exists in Procedure XDP-PD-0001.
This revision will eliminate the conflict in the procedures pertaining to the contractor appeal process. The FFDPM agreed to complete the revision to the procedure within 30 days after receipt of the inspection report (483/93021-02)
c.
An inspection finding was noted nertaining to the need for more readily available written instructions for personnel being FFD tested.
Section 2.2(d)(3) of Appendix A to 10 CFR Part 26 requires individuals subject to FFD testing to be provided standard written instructions setting forth their respons-ibilities. The licensee's instructions for personnel responsibilities during FFD testing were contained in Section 8.3 of Procedure APA-ZZ-00909 for contractor personnel and Procedure APA-ZZ-00908 for licensee personnel.
Interviews disclosed that the procedures noted above were available if the individuals requested a copy of the procedure during inprocessing.
Otherwise, the written instructions may or may not be reviewed as a mandatory reading item by various departments.
The FFD staff noted that personnel being FFD tested were verbally briefed on their responsibilities during the testing process. To resolve the issue pertaining to written instructions, the FFDPM agreed to prepare written instructions setting forth personnel FFD responsibilities in reference to FFD testing. Additionally, the written instructions would be readily available at the FFD testing facility (483/93021-03).
d.
An inspection finding was noted pertaining to the need for more adequate control of possible access to individual quantitative FFD test result data. The Medical Review Officer (MRO) often requested quantitative FFD test data for positive FFD test results. Section 2.7(g)(3) of Appendix A to 10 CFR Part 26 prohibits distribution of individual FFD quantitative results to licensee management except if an appeal is being processed, Although there was no evidence that licensee management personnel were provided quantitative data for individual test results, some quantitative data for individual test results was openly filed in file folders within the FFD record storage area. Although all personnel having access to such record data, to include administrative personnel, were designated in writing and screened as part of the FFD staff, the practice could allow access to FFD individual test results by personnel performing only administrative functions.
To resolve this concern, the FFDPH agreed to maintain all quantitative data for individual FFD test results in sealed envelopes (483/93021-04).
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Three program strengths were noted during the inspection and are e.
addressed below.
(1)
The FF0 facilities were of excellent quality, sufficient in space to provide facilities for the MR0, FFD record storage, and the collection site personnel. Observed housekeeping standards within the licensee testing facility and the other FFD facilities were excellent.
(2)
The inspector observed all three of the FFD staff during the specimen collection process. The process was completed correctly and personnel being tested were treated in a courteous and professional manner. The personnel observed (two of which were Registered Nurses) were completely knowledgeable of their responsibilities and duties. Strong supervision of day-to-day activities was evident.
(3)
The most recent audit of the onsite portions of the FFD program was conducted between December 14-22, 1992 (Audit Report No. AP92-025, dated January 20,1993).
The scope and depth of the audit were excellent, and the audit results were technically correct and well documented.
"Opportuni-ties for improvement" were also id!ntified during the audit process.
6.
Protected Area Unescorted Access Authorization (IP 81070)
Two instances of premature access authorization to the protected area were reviewed and determined to qualify as licensee identified violations in accordance with the criteria in Section VII.B of 10 CFR Part 2, Appendix C (1993).
In both instances, the individual was subsequently qualified for unescorted access to the protected area so an incident of a person not eligible for unescorted access being granted access did not occur. The two incidents of premature access authorization are addressed below:
a.
On September 21, 1993, a contractor employee was issued a security badge about 4 to 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> before the psychological evaluation clinical interview results were received. The clinical interview results were satisfactory and the individual's unescorted access continued.
b.
On October 2, 1993, a contractor employee was granted unescorted access to the protected area without confirming that all of the screening requirements had been completed. The contractor's employer sent a letter (dated September 27,1993) to the licensee requesting that the licensee process a transfer of unescorted access authorization (NUMARC 91-03 form) for the individual who was at Three Mile Island at the time. On October 2, 1993, the licensee (UE) access authorization personnel mistook the " request to process" a transfer as an " access authorization letter" from the contractor and unescorted access to the protected area was
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granted.
(Both the request letter and the access authorization letter used by the contractor are basically the same format and the contractor's access authorization program was approved by the licensee).
The error was not noted until November 3, 1993, when
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another utility requested access authorization information about the person.
Subsequent to November 3, 1993, the licensee's Quality Assurance Department confirmed that the contractor employee had completed all of the screening (background investigation) requirements prior to October 2, 1993, and there was no derogatory information that would have caused denial of access authorization.
The above incidents resulted in the licensee granting unescorted access to the protected area before confirming that the requirements of 10 CFR 73.56(b)(2)(1) (background investigation)
and 10 CFR 73.56(b)(2)(ii) (psychological evaluation) had been completed.
Both of the incidents noted above were attributed to personnel error.
Both of the incidents were logged as security incidents to be reported to the NRC.
Corrective action to prevent recurrence consisted of implementing a computerized checklist which will verify that the elements of background screening which are being entered in the computer are completed before a security badge is issued.
These incidents meet the criteria of Section VII.B of 10 CFR Part 2 of Appendix C as a licensee identified violation.
7.
Unresolved Item Unresolved items are matters about which more information is required in order to ascertain whether it is an acceptable item, a violation, a failure to meet a licensee commitment, or a deviation. An unresolved item is discussed in paragraph 5.a.
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hrfqgr December 14, 1993 Donald r. Schnett ILLECTIU,,,C
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E creed Chief, Safeguardc Section U.S. flaclear Regulatori Conmission Region I:1 799 Roosevelt Roac Glen '..
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I ?;S P E CTIOf; REPORT ?;0. 50-483/9302; VIOLATIO!!
On Decc.ber 5,
1492, during the e x 1 *,
eeting i c:
- i t ne s c - Fo r-ilu t y nspect ion f: mber 9 3 02 ',, the ':F C found t'nion Moctric t o
.m in 'iolation c: 100FR2G Jcr fa;1ure tc neriern annual aud:tc at HiiS certi+2ed laborateries whicr
'rovic tenting 'ervices- :or cur FFS program.
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{1ect:.c ri o e s act acroe eitn he !!PC's positicr.
Thic lettc:
'mvides -~ baci: 10: our I;e.iet that
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Section 2G.50 of the FFD rule addrecsss audit
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Paraaraph 20.00(c) prcvides !!RC guidelines for licensee audito c HHS-certified laboratories and references i.ppencix A of the rule.
In our reading of Appendix A, paragraph 2.7(m) provides the only discussion c: licensee audit requirenents for laboratories.
This paracraph requires licensees to carry out pre-award inspections and evaluation of the procedural ascects of laboratory drug testing operations prior to award of a contract.
We met this requ:rement by performance of pre-award audito of both labs under contract to UE.
Appendix A does not require annual audits cf labs.
We are, therefore, in full compliance with /sppendi>. Is audit t
reotirements.
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paragraph 26.80(a) addresses conduct of audits,
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nominally every 12 months, for fitness-for-duty programs implemented by licensee contractors and vendors.
Section 26.3 specifically defines contractors and vendors to include individuals and companies performing work or cervices in the protected area of nuclear power plants.
The definition does not~ i nclude offsite laboratcries.
We have reviewed our audits of contractors and vendorc and determined that we are in full compliance with the prescribed frequencies for cuch auditc as detinea b)
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ULNRC 0292'. -
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the rule.. Thorough review of Part 26, Appendix is, liUREGs
_ 1385,'and the Statements of Consideration for Part 1354 and 26 identified no requirement for periodic audit of HHS labs atter the pre-award audit.
Based-on this: review,'and the
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preceding discussion of the requirements of the rule, believe'no violation exists.
we 1:e recuest the NRC to consider ru: : :sition in.
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four revie 71 this issue.
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